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Erytech Pharma SA Announces Positive DSMB Review of Its Phase IIB Study into Acute Myeloid Leukemia


Monday, 11 Nov 2013 12:00pm EST 

Erytech Pharma SA announced that an independent Data and Safety Monitoring Board (DSMB) completed its first assessment of the Company`s Phase IIb study in Acute Myeloid Leukemia (AML) study and unanimously recommended continuation of the trial without modification. The GRASPA-ML study is a multicentre, randomized, controlled Phase IIb trial evaluating efficacy and tolerability of GRASPA in the treatment of newly diagnosed AML patients over 65 years old that are unfit for intensive chemotherapy. In this 123-patient study, one-third of the patients receive the current standard treatment (low-dose cytarabine) and two-thirds receive low-dose cytarabine plus GRASPA. The study was initiated in March 2013 and is performed in collaboration with Orphan Europe (Recordati Group), Erytech Pharma SA's partner for the commercialization of GRASPA in 38 European countries. DSMB is an external committee of independent clinical research experts who review data in ongoing clinical trials with particular attention to safety. The DSMB assessment was based on a pre-planned safety analysis on the first 30 patients included in the study and with a minimum of 1 month follow-up. A second DSMB review is planned when 60 patients will be treated in the study. 

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